HypertensionPhase 3NCT00299832
SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
A Phase 3 study testing Aliskiren in people with Hypertension, run by Novartis at 1 site in Japan.
Trial summary
Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aliskiren
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2006to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20 - 80 years old
- Gender: Male or female
- Status: Outpatients
- Elevated Serum Creatinine
Who cannot join
- Patients suspected of malignant hypertension
- Patients with a clinically significant allergy
- Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction
- Conditions
- Hypertension
- Being tested
- Aliskiren
- Keywords
- Hypertension, aliskiren, blood pressure, rennin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events after 8 weeks
Secondary outcomes (5)
Change from baseline in mean sitting systolic blood pressure after 8 weeks
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Blood pressure <140/90 after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299832
- Sponsor's protocol ID
- CSPP100A1303
- Status last verified
- Nov 2016
- First submitted
- 3 Mar 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res. 2010 Jan;33(1):62-6. doi: 10.1038/hr.2009.175. Epub 2009 Nov 20.
PubMed 19927154
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
- ClinicalTrials.gov ID
- NCT00299832
- Acronym / sponsor ID
- CSPP100A1303
- Conditions
- Hypertension
- Keywords
- Hypertension, aliskiren, blood pressure, rennin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 7 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 20 - 80 years old
- Gender: Male or female
- Status: Outpatients
- Elevated Serum Creatinine
Key exclusion criteria (3 listed)
- Patients suspected of malignant hypertension
- Patients with a clinically significant allergy
- Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aliskiren | Drug | – |
Primary outcome
Adverse events after 8 weeks
5 secondary outcomes
Change from baseline in mean sitting systolic blood pressure after 8 weeks
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Blood pressure <140/90 after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: PubMed 19927154Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res. 2010 Jan;33(1):62-6. doi: 10.1038/hr.2009.175. Epub 2009 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis study chair
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren in people with Hypertension, run by Novartis at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events after 8 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.